Hepatitis DMPR_BDNCT06504485
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
An observational study of Hepatitis D, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Pharmacological, single-center, non-profit observational study. The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D
- What is being tested?
- Bulevirtide
- Type of treatment
- Injection or infusion
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients co-infected with HBV-HDV (defined by positivity of HDV RNA for at least 6 months) who meet the inclusion criteria and no exclusion criteria
Who may be able to join
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.
Who cannot join
- Co-infection with other viruses (HCV, HIV)
- Treatment with immunosuppressive/immunomodulatory drugs
- Other congenital and/or acquired immunodeficiency conditions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, 20122
About this study
Official title: Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment
Pharmacological, single-center, non-profit observational study.
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).
Read more
Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.
The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).
- Conditions
- Hepatitis D
- Being tested
- Bulevirtide
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulevirtideDrug
dose of 2 mg/day subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Hepatis Delta naive | Patients with HDV infection naïve to Bulevirtide therapy | |
| Hepatis Delta in therapy | Patients with HDV cirrhosis consecutively started on Bulevirtide therapy during the study enrollment period Receives: Drug: Bulevirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
Measured: through study completion, an average of 2 year
Change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment)
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection after 12 months of treatment with Bulevirtide compared to baseline (pre-therapy)
Measured: Month 12
Secondary outcomes (12)
Correlate HDV-specific T cell response with stage of liver disease
Correlation of HDV-specific T cell response with stage of liver disease
Measured: through study completion, an average of 2 year
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease
Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with the stage of liver disease
Measured: through study completion, an average of 2 year
Correlate the quantification of HDV RNA within exosomes with the stage of liver disease
Correlation between the quantification of HDV RNA within exosomes and the disease phenotype
Measured: through study completion, an average of 2 year
Investigate the correlation between the genetic heritage of HDV and the stage of liver disease
Correlation between the genetic heritage of HDV and the stage of liver disease
Measured: through study completion, an average of 2 year
Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection
Transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection
Measured: through study completion, an average of 2 year
Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance
Correlation between HDV mutations and the ability of the virus itself to escape CD8 T cell surveillance
Measured: through study completion, an average of 2 year
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Correlation between the change in HDV-specific T responses
Measured: Month 6
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Correlation between the change in HDV-specific T responses
Measured: Month 18
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Correlation between the change in HDV-specific T responses
Measured: through study completion, an average of 2 year
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide;
Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with response to treatment with Bulevirtide
Measured: through study completion, an average of 2 year
Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment
Correlation between the quantification of HDV RNA within exosomes and the response to treatment with Bulevirtide
Measured: through study completion, an average of 2 year
Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide
Correlation between HDV genetic heritage and response to treatment with Bulevirtide
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Nov 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Parma University Hospital, University of Rome Tor Vergata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504485
- Sponsor's protocol ID
- P2022WEXP2
- Acronym
- MPR_BD
- Status last verified
- Dec 2025
- First submitted
- 5 Jul 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment
- ClinicalTrials.gov ID
- NCT06504485
- Acronym / sponsor ID
- MPR_BD / P2022WEXP2
- Conditions
- Hepatitis D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milan, Parma University Hospital, University of Rome Tor Vergata
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacological, single-center, non-profit observational study.
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).
Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.
The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatis Delta naive | – | –Patients with HDV infection naïve to Bulevirtide therapy |
| Hepatis Delta in therapy | – | Drug: BulevirtidePatients with HDV cirrhosis consecutively started on Bulevirtide therapy during the study enrollment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients co-infected with HBV-HDV (defined by positivity of HDV RNA for at least 6 months) who meet the inclusion criteria and no exclusion criteria
Key inclusion criteria (3 listed)
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.
Key exclusion criteria (3 listed)
- Co-infection with other viruses (HCV, HIV)
- Treatment with immunosuppressive/immunomodulatory drugs
- Other congenital and/or acquired immunodeficiency conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulevirtidedose of 2 mg/day subcutaneously | Drug | Hepatis Delta in therapy |
Primary outcome
Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
Time frame: through study completion, an average of 2 year
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
Change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment)
Time frame: Month 12
Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection after 12 months of treatment with Bulevirtide compared to baseline (pre-therapy)
12 secondary outcomes
Correlate HDV-specific T cell response with stage of liver disease
Time frame: through study completion, an average of 2 year
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease
Time frame: through study completion, an average of 2 year
Correlate the quantification of HDV RNA within exosomes with the stage of liver disease
Time frame: through study completion, an average of 2 year
Investigate the correlation between the genetic heritage of HDV and the stage of liver disease
Time frame: through study completion, an average of 2 year
Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection
Time frame: through study completion, an average of 2 year
Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance
Time frame: through study completion, an average of 2 year
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Time frame: Month 6
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Time frame: Month 18
Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Time frame: through study completion, an average of 2 year
Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide;
Time frame: through study completion, an average of 2 year
Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment
Time frame: through study completion, an average of 2 year
Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.